Received Mar 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
increased neuropathy symptoms; showed abnormal kidney function bloodwork; carpel tunnel; has rash in groin area; Unable to sleep; itchy eyes; feeling well in the month; mild depression; This serious case was reported by a consumer via other manufacturer and described the occurrence of neuropathy in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included tafamidis (Vyndamax) (batch number 6327108A) for amyloidosis. The patient's past medical history included diarrhea. Previously administered products included Mounjaro. Concurrent medical conditions included amyloidosis (Transthyretin-Related Amyloidosis) and drug allergy (CT Scan Dye). On an unknown date, the patient received Shingles vaccine. On 21-JAN-2025, the patient started Vyndamax (oral) 61 mg twice a day (122 mg daily). In JAN-2026, an unknown time after receiving Shingles vaccine and an unknown time after starting Vyndamax, the patient experienced depression (Verbatim: mild depression) and feeling unwell (Verbatim: feeling well in the month). On an unknown date, the patient experienced neuropathy (Verbatim: increased neuropathy symptoms) (serious criteria GSK medically significant), renal impairment (Verbatim: showed abnormal kidney function bloodwork) (serious criteria GSK medically significant), carpal tunnel syndrome (Verbatim: carpel tunnel), rash (Verbatim: has rash in groin area), insomnia (Verbatim: Unable to sleep) and eye pruritus (Verbatim: itchy eyes). The action taken with Vyndamax was unknown. The outcome of the neuropathy, renal impairment, carpal tunnel syndrome, rash, insomnia, depression, eye pruritus and feeling unwell were unknown. It was unknown if the reporter considered the neuropathy, renal impairment, carpal tunnel syndrome, rash, insomnia, depression, eye pruritus and feeling unwell to be related to Shingles vaccine. The reporter considered the neuropathy, renal impairment, carpal tunnel syndrome, rash, insomnia, depression, eye pruritus and feeling unwell to be not reported if related to Vyndamax. The company considered the neuropathy and renal impairment to be unrelated to Shingles vaccine. It was unknown if the company considered the carpal tunnel syndrome, rash, insomnia, depression, eye pruritus and feeling unwell to be related to Shingles vaccine. The company considered the neuropathy, renal impairment, carpal tunnel syndrome, rash, insomnia, depression, eye pruritus and feeling unwell to be not reported if related to Vyndamax. Additional Information: GSK Receipt Date:25-FEB-2026 The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Neuropathy peripheral and Renal impairment, unknown time after receiving Shingles vaccine in a 79-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (concurrent amyloidosis and concomitant tafamidis).
Amyloidosis (Transthyretin-Related Amyloidosis); Drug allergy (CT Scan Dye)
Medical History/Concurrent Conditions: Diarrhea
VYNDAMAX
Test Name: Blood test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:) abnormal kidney function